Hepatocellular CarcinomaPhase 1/2NCT06463522
Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma
A Phase 1/2 study testing Autologous Tumor-infiltrating Lymphocytes in people with Hepatocellular Carcinoma, run by Beijing 302 Hospital at 1 site in China.
Trial summary
This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Autologous Tumor-infiltrating Lymphocytes
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years;
- Diagnosis of HCC with BCLC stage B/C;
- Anticipated survival time is longer than 3 months;
- Liver function grade Child-Pugh A or B, without hepatic encephalopathy;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- ECOG physical status 0-2;
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- Laboratory tests at baseline meet the following: Absolute neutrophil count >1.0 x 109/L; Absolute neutrophil count >1.0 x 109/L; White blood cell count > 2.0 x 109/L; Platelet count > 60 x 109/L; Hgb > 8.0 g/dL; ALT and AST ≤ 5 times the upper limit of normal (ULN), Serum total bilirubin (TBiL) ≤ 51 mmol/L, or < 3 times the ULN.
- Female subjects of childbearing potential must take acceptable measures to minimize the likelihood of pregnancy during the trial. Female subjects of childbearing potential must have a negative serum or urine pregnancy result within 48 hours prior to treatment;
- Able to receive treatment and follow-up, including the need for the subject to receive treatment at the enrollment center.
Who cannot join
- Pregnant or breastfeeding women;
- WIth HIV/AIDS infection;
- Active infection with a temperature >38.3°C prior to study treatment and have been treated with antibiotics within 2 weeks prior to enrollment;
- Presence of the following pre-existing or concomitant diseases: Prior diagnosis of a severe autoimmune disease requiring systemic immunosuppression (steroids) for a prolonged period of time (more than 2 months), or immune-mediated symptomatic disease; Prior diagnosis of autoimmune-induced motor neuron disease; Prior toxic epidermal necrolysis release; Subjects with any psychiatric condition, including dementia, altered mental status, which may interfere with treatment in this study; Subjects with other malignancies in the previous 5 years; Subjects with heart failure ≥ grade 2 (NYHA) or hypertension uncontrolled by standard therapy; Subjects with unstable or active peptic ulcer or gastrointestinal bleeding; Subjects with serious uncontrollable disease, as determined by the study, that may interfere with treatment in this study;
- Subjects undergoing treatment with systemic steroids;
- Subjects who have previously used immune cell therapy (CIK, DC, DC-CIK, LAK therapy) and are less than 28 days from the end of treatment to screening;
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- Subjects who are allergic to cell therapy products or related drugs;
- Subjects who have previously received an organ transplant or are planning to receive an organ transplant;
- Subjects requiring anticoagulant therapy (warfarin or heparin);
- Subjects who are judged by the investigator to be unsuitable for participation in this study due to other conditions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Fifth Medical Center of PLA
Beijing
Junliang Fu, PhD, MD, 86-10-66933214, fjunliang@163.com
Fu-Sheng Wang, PhD, MD, 86-10-66933328, fswang302@163.com
About this study
This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Autologous Tumor-infiltrating Lymphocytes
- Keywords
- Hepatocellular Carcinoma, Tumor-infiltrating Lymphocytes
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Tumor-infiltrating LymphocytesProcedure or surgery
Autologous Tumor-infiltrating Lymphocytes, 2.0*10^7/Kg, single intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Tumor-infiltrating Lymphocytes Therapy | Experimental | Autologous Tumor-infiltrating Lymphocytes Therapy, 2.0*10^7/Kg, single intravenous infusion. Receives: Procedure: Autologous Tumor-infiltrating Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability of Autologous Tumor-infiltrating Lymphocytes Therapy
Measured: day0, day3, week1, week2, week4, week12, week24
Secondary outcomes (3)
Concentration of Total Bilirubin (TBIL, mg/dL)
Total bilirubin refers to the concentration of bilirubin in a patient's blood sample, which is automatically measured by the laboratories in accordance with standard operating procedures.
Measured: day0, day3, week1, week2, week4, week12, week24
Child-Turcotte-Pugh(CTP) score
CTP score is currently the most commonly used model to evaluate liver reserve function and prognosis in patients with cirrhosis. This model evaluates liver function based on HE grade, degree of abdominal fluid accumulation, bilirubin (TBiL), albumin (Alb) and prothrombin time (PT). The score ranges from 0 to 15, with the higher the score, the worse the prognosis.
Measured: day0, day3, week1, week2, week4, week12, week24
Quality of life of patients
Quality of life assessed by Functional Assessment of Cancer Therapy - Hepatobiliary Symptom Index， which has a score ranges 0-32, a higher score indicates better quality of life.
Measured: day0, day3, week1, week2, week4, week12, week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Autologous Tumor-infiltrating Lymphocytes Therapy
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junliang Fu, PhD, MD, Principal investigator, the Fifth Medical Center of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463522
- Sponsor's protocol ID
- KY-2024-3-48-2
- Status last verified
- Jun 2024
- First submitted
- 26 Apr 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06463522
- Acronym / sponsor ID
- KY-2024-3-48-2
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Tumor-infiltrating Lymphocytes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Autologous Tumor-infiltrating Lymphocytes Therapy
| Arm | Type | Receives |
|---|---|---|
| Tumor-infiltrating Lymphocytes Therapy | Experimental | Procedure: Autologous Tumor-infiltrating LymphocytesAutologous Tumor-infiltrating Lymphocytes Therapy, 2.0*10^7/Kg, single intravenous infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to 70 years;
- Diagnosis of HCC with BCLC stage B/C;
- Anticipated survival time is longer than 3 months;
- Liver function grade Child-Pugh A or B, without hepatic encephalopathy;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women;
- WIth HIV/AIDS infection;
- Active infection with a temperature >38.3°C prior to study treatment and have been treated with antibiotics within 2 weeks prior to enrollment;
- Presence of the following pre-existing or concomitant diseases: Prior diagnosis of a severe autoimmune disease requiring systemic immunosuppression (steroids) for a prolonged period of time (more than 2 months), or immune-mediated symptomatic disease; Prior diagnosis of autoimmune-induced motor neuron disease; Prior toxic epidermal necrolysis release; Subjects with any psychiatric condition, including dementia, altered mental status, which may interfere with treatment in this study; Subjects with other malignancies in the previous 5 years; Subjects with heart failure ≥ grade 2 (NYHA) or hypertension uncontrolled by standard therapy; Subjects with unstable or active peptic ulcer or gastrointestinal bleeding; Subjects with serious uncontrollable disease, as determined by the study, that may interfere with treatment in this study;
- Subjects undergoing treatment with systemic steroids;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Tumor-infiltrating LymphocytesAutologous Tumor-infiltrating Lymphocytes, 2.0*10^7/Kg, single intravenous infusion. | Procedure or surgery | Tumor-infiltrating Lymphocytes Therapy |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: day0, day3, week1, week2, week4, week12, week24
Safety and Tolerability of Autologous Tumor-infiltrating Lymphocytes Therapy
3 secondary outcomes
Concentration of Total Bilirubin (TBIL, mg/dL)
Time frame: day0, day3, week1, week2, week4, week12, week24
Child-Turcotte-Pugh(CTP) score
Time frame: day0, day3, week1, week2, week4, week12, week24
Quality of life of patients
Time frame: day0, day3, week1, week2, week4, week12, week24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junliang Fu, PhD, MD principal investigator
the Fifth Medical Center of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Tumor-infiltrating Lymphocytes in people with Hepatocellular Carcinoma, run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junliang Fu, PhD, MD (86-10-66933214, fjunliang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: day0, day3, week1, week2, week4, week12, week24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.